Alzheimer's DiseaseCAREERNCT01380288
Cognitive Changes in Alzheimer's Disease Patients Associated With or Without White Matter Changes After Rivastigmine
A study testing rivastigmine patch in people with Alzheimer's Disease, run by Dong-A University at 16 sites in South Korea.
Trial summary
The purpose of this study is to evaluate and compare the changes of cognitive function (as measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated with and without white matter changes after rivastigmine patch therapy. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- rivastigmine patch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 16 sitesSouth Korea
- Study dates
- Jun 2011to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AD in NINCDS-ADRDA criteria, mild to moderate
- probable AD with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
- MMSE score : 10 to 26 at screening
- Hachinski scores ≤ 4
- No clinically significant laboratory abnormalities, such as thyroid disease, vitamine B12 deficiency or folic acid deficiency
Who cannot join
- Current evidence of history of neurological, psychiatric and other illness that could contribute to dementia
- Subjects with clinical significant cardiovascular disease, stroke, pulmonary disease or any other medical disease in the past 6 months
- History of cancer within the last 5 years
- Subjects with evidence or history of clinically significant allergic reaction to AchEI or drugs
- Subjects who had significant visual or hearing difficulties
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
Holy Family Hospital, The Catholic Univerisy of Korea, School of Medicine
Bucheon-si
Busan National University Hospital
Busan
Busan Paik Hospital, Inje University College of Medicine
Busan
Changwon Fatima Hospital
Changwon
Daegu Fatima Hospital
Daegu
Keimyung University School of Medicine
Daegu
Kyungpook National University School of Medicine
Daegu
Myongji Hospital, Kwandong University College of Medicine
Goyang
Dongguk University International Hospital
Ilsan
National Health Insurance Corporation Ilsan Hospital
Ilsan
Inha University College of Medicine
Incheon
Gyeongsang National University College of Medicine
Jinju
Chonnam National University, Medical School
Kwangju
Seoul National Unviersity College of Medicine, Clinical neuroscience center, Seoul National Unviersity Bundang Hospital
Seongnam
The Catholic Univerisy of Korea, School of Medicine
Seoul
Pusan National University Yangsan Hospital
Yangsan
About this study
Official title: Changes of Cognitive Function in Patients With Mild to Moderate Alzheimer's Disease Associated With or Without White Matter Changes After Rivastigmine Patch Therapy - Multi-center, Prospective, Open-label Clinical Trial
The purpose of this study is to evaluate and compare the changes of cognitive function (as measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated with and without white matter changes after rivastigmine patch therapy.
Read the detailed description
Acetylcholinesterase inhibitors (AChEIs) increase the amount acetylcholine at ACh receptors within the brain, and are the primary medications used to treat AD. Alzheimer's disease patients are frequently associated with mild or moderate white matter changes on MR imaging. The impact of whiter matter changes on the efficacy of cognition, functional abilities, behavioral and psychiatric symptoms and caregiver burden for probable Alzheimer's disease is not well known. There are very few studies for the efficacy of rivastigmine between the patients with mild to moderate Alzheimer's disease associated with or without vascular risk factors.
Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. The investigators hypothesized that rivastigmine patch will provide benefits to AD patients with white matter changes compared to those without any white matter changes. Possible explanation about favorable benefits for AD with white matter changes is that rivastigmine may act on both Alzheimer's and vascular pathologies contributing to dementia, providing additive treatment effects in patients suffering from both conditions concurrently. To our Knowledge, there was no study or clinical trial to compare the changes of cognitive function, ADL, BPSD and caregiver burden in two groups of patient with Alzheimer's disease associated with or without white matter changes after rivastigmine transdermal patch therapy.
- Conditions
- Alzheimer's Disease
- Being tested
- rivastigmine patch
- Keywords
- Alzheimer's disease, rivastigmine patch, white matter change
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rivastigmine patchDrug
Also called Exelon patch
rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
| Study group | Role | What they receive |
|---|---|---|
| without white matter change | Active comparator | Not described Receives: Drug: rivastigmine patch |
| with white matter change group | Active comparator | Not described Receives: Drug: rivastigmine patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of cognitive function as measured by ADAS-Cog
Measured: 24 weeks
Secondary outcomes (6)
MMSE (Mini-Mental State Examination)
Measured: 24 weeks
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Measured: 24 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Measured: 24 weeks
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Measured: 24 weeks
Caregiver burden scale
Measured: 24 weeks
Adverse events
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2016
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University
- Sponsor type
- University, hospital or other
- Collaborators
- Novartis Korea Ltd.
- Responsible party
- Principal investigator, Kyungil Park, Dong-A University
- Investigators
- Kyung Won Park, MD, PhD, Principal investigator, Dong-A University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01380288
- Sponsor's protocol ID
- neuropark
- Acronym
- CAREER
- Status last verified
- Feb 2018
- First submitted
- 21 Jun 2011
- Last updated
- 5 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Park KW, Kim EJ, Han HJ, Shim YS, Kwon JC, Ku BD, Park KH, Yi HA, Kim KK, Yang DW, Lee HW, Kang H, Kwon OD, Kim S, Lee JH, Chung EJ, Park SW, Park MY, Yoon B, Kim BC, Seo SW, Choi SH. Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer's dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial. PLoS One. 2017 Aug 7;12(8):e0182123. doi: 10.1371/journal.pone.0182123. eCollection 2017.
PubMed 28786987
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Cognitive Function in Patients With Mild to Moderate Alzheimer's Disease Associated With or Without White Matter Changes After Rivastigmine Patch Therapy - Multi-center, Prospective, Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT01380288
- Acronym / sponsor ID
- CAREER / neuropark
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, rivastigmine patch, white matter change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Dong-A UniversityUniversity, hospital or other
- Collaborators
- Novartis Korea Ltd.
- Study start
- Jun 2011 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate and compare the changes of cognitive function (as measured by ADAS-Cog) in the two group of patients with Alzheimer's disease (AD) associated with and without white matter changes after rivastigmine patch therapy.
Detailed description
Acetylcholinesterase inhibitors (AChEIs) increase the amount acetylcholine at ACh receptors within the brain, and are the primary medications used to treat AD. Alzheimer's disease patients are frequently associated with mild or moderate white matter changes on MR imaging. The impact of whiter matter changes on the efficacy of cognition, functional abilities, behavioral and psychiatric symptoms and caregiver burden for probable Alzheimer's disease is not well known. There are very few studies for the efficacy of rivastigmine between the patients with mild to moderate Alzheimer's disease associated with or without vascular risk factors.
Recently, the rivastigmine patch demonstrated efficacy comparable to the highest doses of rivastigmine capsules, with markedly improved tolerability profile. The investigators hypothesized that rivastigmine patch will provide benefits to AD patients with white matter changes compared to those without any white matter changes. Possible explanation about favorable benefits for AD with white matter changes is that rivastigmine may act on both Alzheimer's and vascular pathologies contributing to dementia, providing additive treatment effects in patients suffering from both conditions concurrently. To our Knowledge, there was no study or clinical trial to compare the changes of cognitive function, ADL, BPSD and caregiver burden in two groups of patient with Alzheimer's disease associated with or without white matter changes after rivastigmine transdermal patch therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| without white matter change | Active comparator | Drug: rivastigmine patch |
| with white matter change group | Active comparator | Drug: rivastigmine patch |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- AD in NINCDS-ADRDA criteria, mild to moderate
- probable AD with or without mild to moderate whiter matter lesions, excluding multiple large vessel infarcts or a single, strategically placed infarct (angular gyrus, thalamus, basal forebrain, territory of the posterior or anterior cerebral artery) on MRI scan (within 12 months)
- MMSE score : 10 to 26 at screening
- Hachinski scores ≤ 4
- No clinically significant laboratory abnormalities, such as thyroid disease, vitamine B12 deficiency or folic acid deficiency
Key exclusion criteria (5 listed)
- Current evidence of history of neurological, psychiatric and other illness that could contribute to dementia
- Subjects with clinical significant cardiovascular disease, stroke, pulmonary disease or any other medical disease in the past 6 months
- History of cancer within the last 5 years
- Subjects with evidence or history of clinically significant allergic reaction to AchEI or drugs
- Subjects who had significant visual or hearing difficulties
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rivastigmine patchAlso: Exelon patchrivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks | Drug | with white matter change group, without white matter change |
Primary outcome
The changes of cognitive function as measured by ADAS-Cog
Time frame: 24 weeks
6 secondary outcomes
MMSE (Mini-Mental State Examination)
Time frame: 24 weeks
Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Time frame: 24 weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: 24 weeks
Caregiver-Administered Neuropsychiatric Inventory (CGA-NPI)
Time frame: 24 weeks
Caregiver burden scale
Time frame: 24 weeks
Adverse events
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2018.
- Derived from this study: PubMed 28786987Park KW, Kim EJ, Han HJ, Shim YS, Kwon JC, Ku BD, Park KH, Yi HA, Kim KK, Yang DW, Lee HW, Kang H, Kwon OD, Kim S, Lee JH, Chung EJ, Park SW, Park MY, Yoon B, Kim BC, Seo SW, Choi SH. Efficacy and tolerability of rivastigmine patch therapy in patients with mild-to-moderate Alzheimer's dementia associated with minimal and moderate ischemic white matter hyperintensities: A multicenter prospective open-label clinical trial. PLoS One. 2017 Aug 7;12(8):e0182123. doi: 10.1371/journal.pone.0182123. eCollection 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Won Park, MD, PhD principal investigator
Dong-A University
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rivastigmine patch in people with Alzheimer's Disease, run by Dong-A University at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of cognitive function as measured by ADAS-Cog (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01380288, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2018.